Study of Accuracy of New Diagnostic Technology to Determine Guide Rapid Antibiotic Treatment for Serious Infections (RAMPED)
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|ClinicalTrials.gov Identifier: NCT02060513|
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : December 2, 2016
|Condition or disease|
|Infection Skin and Subcutaneous Tissue Bacterial Infections Healthcare-associated Infection Infection Due to Resistant Bacteria|
Current methods for diagnosing infections typically require 2-3 days to produce results that can guide antibiotic choice. That is frequently too delayed to help clinicians make good treatment decisions. This also results in inappropriate or over-treatment with non-targeted antibiotics that are started while awaiting lab results. More rapid technologies that can accurately diagnose the specific cause of an infection could guide early, targeted antibiotic treatment. This would result in more effective early treatment of infection, decrease unnecessary exposure to excess antibiotics, and could slow the development of antibiotic resistance. By diagnosing infections earlier, we expect to reduce the complications and mortality of combat-related infections in Wounded Warriors and Military Veterans.
We propose a new ultra-rapid technology (called MADM) that uses a digital microscope to detect bacteria growing directly from a patient's specimen, rather than waiting for growth in lab cultures. The innovative new method supports identification of the infecting bacteria within 2 hours of receiving a specimen. The technology also shows the effect of selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors know within 6 hours from specimen collection which antibiotic kills the bacteria.
This study involves collection of any excess volume of microbiology specimens after it has been determined sufficient sample is available for clinical care. All microbiological samples and results are being obtained for solely non-research purposes as part of usual care; only leftover/discarded materials from clinical or research procedures already performed will be used for this study. Samples will be tested in tandem with usual care on the new technology to test the accuracy and speed. Results obtained from the new technology will not be used in patient care or to make treatment decisions.
|Study Type :||Observational|
|Actual Enrollment :||2298 participants|
|Observational Model:||Case Control|
|Official Title:||Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
- The proportion of concordant, accurately phenotyped positive isolates assayed by MADM versus conventional culture based microbiology as comparator. [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060513
|United States, Colorado|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|
|Denver Veterans Affairs Eastern Colorado Health Care System|
|Denver, Colorado, United States, 80220|
|United States, Maryland|
|Washington Hospital Center|
|Washington, Maryland, United States, 20782|
|Principal Investigator:||Connie S Price, MD||Denver Health Medical Center|
|Principal Investigator:||Ivor S Douglas, MD||Denver Health Medical Center|